Status quo of phage therapy in United States of America (USA)

Introduction

Bacteriophage acceptance in america
Bacteriophage therapy in America is taking shape although in slow-motion due to some approval protocols from FDA. In recent years the FDA has approved several phage-based trials to be performed and even a prepared phage products manual has been published. This act brought a promising impact on a global health care system since it's of no doubts approval of medication by the FDA is always taken into serious note world wide.  Even in third world countries all over the world, this technology is taking shape seriously and new pioneer scientists even in Africa are performing their outstanding jobs.

Phages as therapy

Though the original discoverer of bacteriophages remains a matter of debate, it’s widely accepted that in 1915, Frederick Twort, a bacteriologist from England, was the first to suggest that it was a virus that was responsible for previous observations of a “factor” that killed bacteria. Two years later, Felix d'Herelle, a microbiologist at the Institut Pasteur in Paris, picked up where Twort left off and first proposed phages as a therapy for human infections. The first known therapeutic use of phages occurred in 1919, when d'Herelle and several hospital interns ingested a phage cocktail to check its safety, then gave it to a 12-year-old boy with severe dysentery. The boy’s symptoms cleared up after a single dose and he fully recovered within a few days. Yet d'Herelle didn’t publish his findings until 1931.

In the 1920s and 30s, researchers around the world continued to study and test phages for their ability to treat bacterial infections in humans. However, most of the results of those studies were published in non-English journals and therefore did not immediately spread to Western Europe and the U.S. In the 1940s, the pharmaceutical company Eli Lilly produced phages for human use in the U.S., and they were marketed to treat a range of bacterial infections, including in wounds and upper respiratory infections. But it was suspected that the phages didn’t work all that well, partly since they were improperly stored or purified, and it was not recognized at the time that many phages were highly selective about the kind of bacteria they infected. Phage therapy fell out of favor in the U.S. and most of Europe with the advent of antibiotics. Only in regions where antibiotics were not as easily accessed — namely what is now Russia, Poland, and the Republic of Georgia — did phage therapy and commercial production continue. However, the phage studies conducted in these regions continued to be non-randomized and uncontrolled, and thus empirical data is still lacking to show that phage therapy was effective.

Current day

Western scientists “re-discovered” phage therapy in the 1980s. Since then, the growing threat of antibiotic-resistant bacterial strains has continued to further interest in phage therapy as a potential alternative. In the 2000s, human experiments began again and data from the first phase I clinical trial in the U.S. was published in 2009. That trial tested the safety of a cocktail of phages specific for E. coliStaphylococcus aureus, and Pseudomonas aeruginosa in 42 patients with chronic leg ulcers. Since it was a phase 1 trial, the study only analyzed safety, not clinical outcomes. No adverse events related to the phages were reported.

UC San Diego Health’s Robert Schooley, MD, and Randy Taplitz, MD, administer intravenous experimental phage therapy for patient Tom Patterson in March 2016, four months after he contracted a multidrug-resistant bacterial infection in Egypt. Credit: UC San Diego Health
UC San Diego Health’s Robert Schooley, MD, and Randy Taplitz, MD, administer intravenous experimental phage therapy for patient Tom Patterson in March 2016, four months after he contracted a multidrug-resistant bacterial infection in Egypt. Credit: UC San Diego Health
Another recent randomized, double-blinded, controlled trial took place in the UK, where researchers tested six bacteriophages in patients with chronic ear infections caused by P. aeruginosa. The number of bacteria significantly decreased in the treated group, those patients also reported that their symptoms eased and there were no adverse events due to treatment. In 2014, researchers in Belgium launched a small clinical trial to test phage therapy in burn victims whose wounds are infected with E. coli or P. aeruginosa bacteria. The results have not yet been fully published, but there were no safety issues reported.

At Yale University, a bacteriophage taken from a local pond was recently used to treat a life-threatening bacterial infection in an 80-year-old man’s chest. That case, described in the May 26, 2016 issue of Scientific Reports, is similar to the UC San Diego treatment of Tom Patterson, but only in the sense that they both used bacteriophages. Success in the Yale case appears to have relied upon the conversion of the bacteria (Pseudomonas aeruginosa) to an antibiotic-sensitive strain.

Until the 2016 case of Tom Patterson at UC San Diego Health, very few, if any, patients in the U.S. have received intravenous phage therapy to directly kill multi-drug resistant bacteria, especially since the advent of antibiotics.

The bacteriophage therapy wasn't and isn't meant to completely fade the use of antibiotics but to repair the system so that we got no bug that is completely left undefeated.

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